FDA.reportPublic FDA data

MAUDE MDR 6697536

MDR report key
6697536
Report number
3007566237-2017-02734
Event key
0
Event type
3
Date of event
2014-09-09
Date received
2017-07-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA WOODWARD CLARK
Address
7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWN IMPLANTABLE NEUROSTIMULATORSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMORMEDTRONIC NEUROMODULATIONMFR3760137601UNKNOWN* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-1001. O

Event Narratives#

N

Patient 1

PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3389 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

RICHIERI, R., BORIUS, PY., CERMOLACCE, M., MILLET, B., LANCON, C., REGIS, J. A CASE OF RECOVERY AFTER DELAYED INTRACRANIAL HEMORRHAGE AFTER DEEP BRAIN STIMULATION FOR TREATMENT-RESISTANT DEPRESSION. BIOL PSYCHIATRY. 2017. DOI: 10.1016/J.BIOPSYCH.2017.04.009 SUMMARY/REPORTED EVENT: A (B)(6) MALE PATIENT WHO HAD RECEIVED BILATERAL NUCLEUS ACCUMBENS (NA) DEEP BRAIN STIMULATION (DBS) FOR TREATMENT RESISTANT DEPRESSION PRESENTED 8 DAYS POST-IMPLANT WITH AN ACUTE CONFUSIONAL SYNDROME WITH APHASIA, PSYCHOMOTOR RETARDATION, SLURRED SPEECH, AND A FRONTAL SYNDROME WITH PREDOMINANT APATHY. A CT SCAN SHOWED A VOLUMINOUS LEFT FRONTAL HEMATOMA ALONG THE ELECTRODE (DIAMETER 55 MM) WITH PERIHEMATOMAL EDEMA, A DELETION OF CORTICAL SULCI, AND A MILD DEFLECTION OF THE MIDLINE. HIS INTRACRANIAL HEMORRHAGE (ICH) WAS MANAGED CONSERVATIVELY, WITHOUT SURGICAL EVACUATION, AND IT RESOLVED SPONTANEOUSLY. AFTER 1 MONTH, COMPUTED TOMOGRAPHY SHOWED A RESORPTION OF THE HEMATOMA WITH THE PRESENCE OF A SEQUELLAR HYPODENSE RANGE. NO MASS EFFECT REMAINED, AND THE DBS LEADS DID NOT SHIFT AWAY FROM THE ORIGINAL TARGET. IT WAS NOTED THAT THE SYMPTOMS ENTIRELY RECOVERED AFTER A 3-MONTH REHABILITATION COURSE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION (I.E. SERIAL NUMBERS) FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR REPORTED THAT THE PATIENT?S BMI WAS (B)(6).

N

Patient 1

SUPPLEMENTAL BEING SENT TO NOTE ADDITIONAL FOLLOW-UP PROVIDING THE DATE OF THE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.